A Study of LY3209590 in Chinese Participants With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LY3209590
Insulin Glargine
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) and treated with basal insulin and up to one non-insulin anti-hyperglycemic medication.
- Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
- Have received a stable daily dose of basal insulin at screening
- Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
- Native Chinese participant who has both parents and all 4 grandparents of Chinese origin.
Exclusion Criteria:
- Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes
- Have a history of ketoacidosis or hyperosmolar state/coma episode or severe hypoglycemia or hypoglycemia unawareness in the 6 months prior to screening
- Are receiving insulin other than once daily basal insulin
- Have any active infectious or serious disease or major organs insufficiency
- Women who are pregnant or lactating
Sites / Locations
- Tianjin Medical University General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LY3209590
Insulin glargine
Arm Description
LY3209590 administered subcutaneously (SC).
Insulin glargine administered SC.
Outcomes
Primary Outcome Measures
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration
Incidence and Severity of Hypoglycemia
Incidence and Severity of Hypoglycemia
Secondary Outcome Measures
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
PD: Change from Baseline in Fasting Plasma Glucose
PD: Change from Baseline in 7-Point Glucose
PD: Change from Baseline in 7-Point Glucose
Full Information
NCT ID
NCT05596747
First Posted
October 25, 2022
Last Updated
September 5, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05596747
Brief Title
A Study of LY3209590 in Chinese Participants With Type 2 Diabetes Mellitus
Official Title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Chinese Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Chinese participants with type 2 diabetes mellitus who are on a stable dose of basal insulin. Side effects and tolerability will be documented. Blood samples will be taken to assess how the body processes the study drug and the effect of the study drug on blood sugar levels. The study will last up to 18 weeks and may include 18 visits for each participant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LY3209590
Arm Type
Experimental
Arm Description
LY3209590 administered subcutaneously (SC).
Arm Title
Insulin glargine
Arm Type
Active Comparator
Arm Description
Insulin glargine administered SC.
Intervention Type
Drug
Intervention Name(s)
LY3209590
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
Administered SC.
Primary Outcome Measure Information:
Title
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration
Time Frame
Baseline up to Week 12
Title
Incidence and Severity of Hypoglycemia
Description
Incidence and Severity of Hypoglycemia
Time Frame
Baseline up to Week 12
Secondary Outcome Measure Information:
Title
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
Description
PD: Change from Baseline in Fasting Plasma Glucose
Time Frame
Baseline through Week 6
Title
PD: Change from Baseline in 7-Point Glucose
Description
PD: Change from Baseline in 7-Point Glucose
Time Frame
Baseline through Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) and treated with basal insulin and up to one non-insulin anti-hyperglycemic medication.
Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
Have received a stable daily dose of basal insulin at screening
Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
Native Chinese participant who has both parents and all 4 grandparents of Chinese origin.
Exclusion Criteria:
Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes
Have a history of ketoacidosis or hyperosmolar state/coma episode or severe hypoglycemia or hypoglycemia unawareness in the 6 months prior to screening
Are receiving insulin other than once daily basal insulin
Have any active infectious or serious disease or major organs insufficiency
Women who are pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY3209590 in Chinese Participants With Type 2 Diabetes Mellitus
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